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Life Sciences
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September 09, 2025
Sandoz, Regeneron Settle Eye Drug Patent Claims
Sandoz Inc. and Regeneron Pharmaceuticals Inc. have reached a settlement to resolve patent claims Regeneron had asserted over a biosimilar alternative to its Eylea ophthalmic disorder drug.
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September 09, 2025
Particle's Antitrust Battle With Epic: 3 Things To Know
Epic Systems Corp. must face allegations it violated federal law by attempting to monopolize a segment of the electronic health records market to the exclusion of competitor Particle Health Inc. Here's what you need to know about the case.
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September 09, 2025
Roberts Pauses Foreign Aid Distribution For Now
Chief Justice John Roberts on Tuesday temporarily stayed a lower court's order requiring the Trump administration to release roughly $4 billion in frozen foreign aid while the U.S. Supreme Court considers a longer-term solution.
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September 09, 2025
Kidney Care Co. Strive Health Secures $550M In New Funding
Kidney care company Strive Health, led by Goodwin Procter LLP, on Tuesday revealed that it has completed a $550 million capital raise, which will be used to help the company enhance its "value-based" care model through advanced technology such as artificial intelligence-driven tools and analytics.
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September 09, 2025
DOJ, FTC Urged To Probe Drugmakers' Rebate Models
The American Hospital Association asked the Trump administration to investigate whether major pharmaceutical companies violated antitrust laws as they push out new rebate models for a program that offers discounted drugs to healthcare providers serving low-income patients.
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September 09, 2025
3rd Circ. Told Cigna's 'Private Label' Stelara May Alter Market
A Johnson & Johnson subsidiary told a Third Circuit panel it would be "difficult" to calculate its potential monetary losses if a Cigna subsidiary were to launch its own version of an anti-inflammatory treatment, particularly if it permanently changed the market by giving the insurance giant a "private label" version that pharmacies would give preference over the original.
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September 08, 2025
NY AG To Fight Texas Bid To Enforce Abortion Ban Ruling
New York Attorney General Letitia James on Monday moved to intervene in a lawsuit brought by the state of Texas that seeks to enforce a money judgment against a New York doctor for providing abortion-inducing drugs to a woman via telemedicine in the Lone Star state.
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September 08, 2025
Oura Domestic Labor Investment Won Import Ban, ITC Says
The U.S. International Trade Commission has found that Ouraring Inc.'s commitments in the U.S. to producing its smart ring warranted the agency's decision to block Ultrahuman and RingConn from importing products it held infringed a wearable computing device patent.
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September 08, 2025
FisherBroyles Can't Nix Stem Cell Patent Malpractice Claim
A California judge on Monday denied FisherBroyles LLP's motion to toss a claim in a $10 million malpractice suit brought against it by a stem cell treatment center, ruling the firm missed a deadline to file the motion.
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September 08, 2025
Whisper Not Enough To Sustain Worker's Harassment Suit
A Pennsylvania federal judge tossed a Merck Sharp & Dohme worker's suit Monday claiming his boss sexually harassed him by whispering in his ear at a staff meeting, ruling the singular incident did not create a hostile work environment at the pharmaceutical company.
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September 08, 2025
Trump Returns To High Court In Foreign Aid Freeze Dispute
President Donald Trump asked the U.S. Supreme Court on Monday to pause a lower court's order requiring the administration to release roughly $4 billion in frozen foreign aid, claiming the ruling interferes with his attempt to lawfully rescind the funding.
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September 08, 2025
FibroGen To Pay SEC $1.25M Over Drug Mistatements
Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.
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September 08, 2025
Catching Up With Delaware's Chancery Court
Last week at the Delaware Court of Chancery, a bankruptcy administrator for a generic drugmaker formerly known as Teligent was told he can proceed with duty of oversight claims against most former officers and directors of the company, who the administrator said was complicit in the company's collapse. In an opinion, the Court of Chancery cites its 1996 decision In re Caremark International Inc. Derivative Litigation, which refined director duties of care and oversight.
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September 08, 2025
23andMe's Ch. 11 Sale Flouted State Privacy Law, Calif. Says
The state of California has asked a Missouri federal judge to undo the $305 million bankruptcy sale of consumer DNA testing group 23andMe, arguing it sidestepped state consumer data protections.
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September 05, 2025
DC Circ. Won't Halt Order Releasing Billions In Foreign Aid
Both a divided D.C. Circuit panel and a district court judge Friday refused to hit pause on the judge's recent order requiring the Trump administration to release billions of dollars in frozen foreign aid.
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September 05, 2025
Stewart Tackles Markets, Injunctions In Newest PTAB Reviews
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart released 14 institution decisions in the last week, providing more insight on the scope of settled expectations and the impact of a district court preliminary injunction.
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September 05, 2025
Federal Agencies Push To Toss Masimo's Apple Watch Suit
U.S. Customs and Border Protection and the U.S. International Trade Commission have again urged a federal judge to throw out Masimo's suit seeking to block a decision allowing imports of redesigned Apple Watches, saying Congress barred court review of such findings.
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September 05, 2025
2nd Circ. Backs Ex-Pfizer Worker's Insider Trading Conviction
The Second Circuit on Friday affirmed a former Pfizer Inc. statistician's insider trading conviction for making $272,000 in options trades from nonpublic news about the success of trials for the COVID-19 therapy drug Paxlovid, rejecting his arguments that prosecutors improperly shifted their legal theory at trial and pursued the case in the wrong venue.
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September 05, 2025
DOJ Pushes To DQ Attorney Over Conflict In Fraud Case
Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."
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September 05, 2025
Merck Shakes Off Some Claims From Cholesterol Drugs Suit
A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.
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September 05, 2025
Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed
Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.
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September 05, 2025
FDA Explains Rejection Of MDMA Therapy For Treating PTSD
The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.
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September 05, 2025
Casper Can't Escape Innovator-Liability Drug Label Suit
A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.
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September 05, 2025
Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit
A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.
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September 05, 2025
Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit
Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.
Expert Analysis
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2 NY Rulings May Stem Foreign Co. Derivative Suits
In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.
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Recent Reports Shed Light On Section 340B's Effectiveness
Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.
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Opinion
Congress Should Pass IP Reform, Starting With 3 Patent Bills
Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.
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Class Standing Issues Still Murky After Justices Punt LabCorp
While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.
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When Reshoring, IP Issues Require A Strong Action Plan
With recent headlines highlighting tariffs as high as 3,521%, more firms will contemplate reshoring manufacturing to the U.S., and they will need to consider important intellectual property issues as part of this complex, expensive and lengthy undertaking, say attorneys at Norton Rose.
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Series
Volunteering At Schools Makes Me A Better Lawyer
Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.
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5 Open Questions About FDA's AI-Assisted Review Plans
The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.
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Prospects And Challenges For Expert Evidence At The UPC
Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.
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Attacks On Judicial Independence Tend To Manifest In 3 Ways
Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.
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Series
Law School's Missed Lessons: Appreciating Civil Procedure
If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.
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Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use
The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.
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In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable
The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.
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Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity
Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.
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What FCA Liability Looks Like In The Cybersecurity Realm
Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say attorneys Rachel Rose and Julie Bracker.
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Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling
After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.